Actively Recruiting

Age: 18Years +
All Genders
ID06774781

Assessment of ADC Values and Radiomic Characteristics Using Multiparametric MRI of the Prostate to Identify Clinically Significant Tumor Lesions

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-14

120

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether specific values found in multiparametric magnetic resonance imaging (RMmp) images, such as Apparent Diffusion Coefficient (ADC) values and radiomics characteristics, can help detect prostate cancer. This observational study focuses on patients who underwent RMmp imaging at the IRCCS Azienda Ospedaliero-Universitaria hospital in Bologna between September 2015 and March 2021. The study aims to understand if analyzing these image features can improve identification of clinically significant prostate tumors. Participants undergo RMmp scans from which ADC values of suspicious lesions and healthy prostate tissue are extracted. Radiomics features are analyzed by medical physicists and engineers after image de-identification. Clinical data is collected by urologists while histological data is gathered by pathologists. All anonymized data is compiled into a shared database among the involved medical teams for analysis. During the study, participants provide informed consent and undergo targeted biopsies guided by fusion technique, as well as systematic biopsies if indicated. Researchers monitor the distribution of ADC values from enrollment through the treatment period, which lasts up to four years. The study focuses on gathering clinical, radiological, and histological data to assess the potential of imaging features in predicting prostate cancer presence and significance.

CONDITIONS

Official Title

Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of one or more lesions classified as PI-RADSv2.1  3 on a prostate multiparametric MRI at IRCCS Azienda Ospedaliero-Universitaria in Bologna
  • Indication for eco-guided targeted biopsy using fusion technique integrated with systematic biopsy
  • Indication for radical prostatectomy
  • Participants aged 18 years or older at the time of examination
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • Inability to perform MRI due to claustrophobia, obesity, or other contraindications
  • MRI scans that are technically suboptimal due to artifacts such as hip prosthesis or endorectal probe movement

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

C

Caterina Gaudiano, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Assessment of ADC Values and Radiomic Characteristics Using Multiparametric MRI of the Prostate to Identify Clinically Significant Tumor Lesions | DecenTrialz